CARDIAC VALVE, SYSTEM, AND METHOD

• US 20090287298A1
• Filed: 07/23/2009
• Published: 11/19/2009
• Est. Priority Date: 09/02/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Jenson, Mark L., Drasler, William J., Lafontaine, Daniel M.
• Granted Patent: US 8,002,824 B2
• Time in Patent Office: Days
• US Class Current: 623/1.240
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

A cardiac valve with a support frame having a first end member and a second end member opposing the first end member in a substantially fixed distance relationship, and a cover extending over the support frame to allow for unidirectional flow of a liquid through the valve.

Claims

1. A system, comprising:

a cardiac valve, where the cardiac valve includes;

a support frame having a first end member and a second end member separated from the first end member by a number of cross members that define a lumen;

a cover at the second end member to form a first valve leaflet and a second valve leaflet, where a portion of the first valve leaflet and the second valve leaflet join to form a reversibly sealable opening for unidirectional flow of a liquid through the cardiac valve; and

a tubular member of the cardiac valve having a predetermined length extending from and in fluid tight communication with the cover, where the tubular member includes a first end on a first side of the first and second valve leaflets and a second end on a second side of the first and second valve leaflets opposite the first side to allow for fluid communication across the valve when the first and second valve leaflets are in a closed position and where the first end and the second end of the tubular member are positionable within and stay within a patient'"'"'s body after removal of a delivery catheter; and

a catheter including a proximal end and a distal end, the cardiac valve located between the proximal end and distal end of the catheter.

2. The system of claim 1, where the catheter includes an elongate body having a lumen longitudinally extending to the distal end, a deployment shaft positioned within the lumen, and a sheath positioned adjacent the distal end, the cardiac valve positioned at least partially within the sheath and adjacent the deployment shaft, where the deployment shaft moves within the lumen to deploy the cardiac valve.

3. The system of claim 1, where the catheter includes an elongate body and a retractable sheath over at least a portion of the elongate body, the cardiac valve positioned at least partially within the retractable sheath, where the retractable sheath moves along the elongate body to deploy the cardiac valve.

4. The system of claim 1, where the catheter includes an inflatable balloon positioned adjacent the distal end and a lumen longitudinally extending in an elongate body of the catheter from the inflatable balloon to the distal end, the inflatable balloon at least partially positioned within the lumen of the cardiac valve, where the inflatable balloon inflates to deploy the cardiac valve.

5. The system of claim 1, where the tubular member includes a predetermined bend between the first end and the second end.

6. The system of claim 1, where the second end member includes a first convex curve and a second convex curve;

and

the cover extends between the first convex curve and the second convex curve to form the first valve leaflet and the second valve leaflet of a bi-leaflet cardiac valve.

7. The system of claim 6, where the cover extends over an outer surface of the support frame to form the bi-leaflet cardiac valve.

8. The system of claim 7, where the cover extends over both an inner surface and the outer surface of the support frame to form the bi-leaflet cardiac valve.

9. The cardiac valve of claim 1, where the cover extends between convex curves of the second end member to form a first valve leaflet, a second valve leaflet, and a third valve leaflet of a tri-leaflet cardiac valve;

and

where a portion of the first valve leaflet, the second valve leaflet and the third valve leaflet join to form the reversibly sealable opening for unidirectional flow of the liquid through the cardiac valve.

10. The system of claim 1, where the first end member defines an open area between a sequence of convex curves and concave curves of the first end member.

11. The system of claim 1, where the cover further includes a surface defining an opening, where the tubular member extends from and is in fluid tight communication with the opening.

12. A method, comprising:

providing a support frame, where the support frame includes a first end member and a second end member opposing the first end member;

providing a cover, where the cover extends between the second end member to form a first valve leaflet and a second valve leaflet of a cardiac valve, a portion of the first valve leaflet and the second valve leaflet joining to form a reversibly sealable opening for unidirectional flow of a liquid through the cardiac valve; and

coupling a tubular member having a predetermined length extending from and in fluid tight communication with the cover, where the tubular member includes a first end on a first side of the first and second valve leaflets and a second end on a second side of the first and second valve leaflets opposite the first side to allow for fluid communication across the valve when the first and second valve leaflets are in a closed position and where the first end and the second end of the tubular member are positionable within and stay within a patient'"'"'s body after removal of a delivery catheter.

13. The method of claim 12, where the second end member includes a first convex curve and a second convex curve;

and

providing the cover includes providing the cover between the first convex curve and the second convex curve to form the first valve leaflet and the second valve leaflet of a bi-leaflet cardiac valve.

14. The method of claim 12, where the second end member includes a first convex curve, a second convex curve, and a third convex curve;

and

providing the cover includes providing the cover between the first convex curve, the second convex curve, and the third convex curve to form the first valve leaflet, the second valve leaflet and a third valve leaflet of a tri-leaflet cardiac valve, where a portion of the first valve leaflet, the second valve leaflet and the third valve leaflet join to form the reversibly sealable opening for unidirectional flow of the liquid through the cardiac valve.

15. The method of claim 12, including defining an open area between a sequence of convex curves and concave curves at the first end member.

16. The method of claim 12, including reversibly joining the cardiac valve to a delivery catheter.

17. The method of claim 16, where reversibly joining the cardiac valve and the catheter includes positioning the cardiac valve at least partially within a sheath of the catheter.

18. The method of claim 17, where positioning the cardiac valve at least partially within the sheath of the catheter includes positioning the cardiac valve adjacent a deployment shaft of the catheter.

19. The method of claim 17, where the sheath includes a retractable sheath of the catheter.

20. The method of claim 17, where the catheter includes an inflatable balloon, the inflatable balloon at least partially positioned within the lumen of the cardiac valve;

and

inflating the balloon to deploy the cardiac valve.